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NCT02159495 · ClinicalTrials.gov registry record · Phase 1
Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
A Phase 1 study of Acute Myeloid Leukemia and Recurrent Adult Acute Myeloid Leukemia, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT02159495: Active Phase 1 study of Acute Myeloid Leukemia and Recurrent Adult Acute Myeloid Leukemia, sponsored by City of Hope Medical Center.
NCT02159495 is a Phase 1 study of Acute Myeloid Leukemia and Recurrent Adult Acute Myeloid Leukemia that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 31 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02159495, a Phase 1 study of Acute Myeloid Leukemia and Recurrent Adult Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and the best dose of genetically modified T-cells after lymphodepleting chemotherapy in treating patients with acute myeloid leukemia or blastic plasmacytoid dendritic cell neoplasm that has returned after a period of improvement or has not responded to previous treatment. An immune cell is a type of blood cell that can recognize and kill abnormal cells in the body. The immune cell product will be made from patient or patient's donor (related or unrelated) blood cells. The immune cells are changed by inserting additional pieces of deoxyribonucleic acid (DNA) (genetic material) into the cell to make it recognize and kill cancer cells. Placing a modified gene into white blood cells may help the body build an immune response to kill cancer cells.
Primary Outcome
Rates and associated 95% Clopper and Pearson binomial confidence limits will be estimated. Tables will summarize all toxicities and side effects by attribution of treatment, dose, time-post treatment, organ and severity. Analysis will be done separately for each disease arm.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG Fludarabine Phosphate
- DRUG cyclophosphamide
- BIOLOGICAL Autologous CD123CAR-CD28-CD3zeta-EGFRt-expressing T Lymphocytes
- BIOLOGICAL Allogeneic CD123CAR-CD28-CD3zeta-EGFRt-expressing T-lymphocytes
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2015-12-15 |
| Est. Completion | 2026-08-06 |
| Phase | Phase 1 |
What the registry record for NCT02159495 still lists
NCT02159495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (73% lower).
The record links to 10 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT02159495 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02159495 about?
NCT02159495 is a clinical study titled "Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm". This phase I trial studies the side effects and the best dose of genetically modified T-cells after lymphodepleting chemotherapy in treating patients with acute myeloid leukemia or blastic plasmacytoid dendritic cell neoplasm that has returned after a period of improvement or has not responded to pr...
What is the current status of trial NCT02159495?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2015-12-15. Estimated completion is 2026-08-06.
What conditions does trial NCT02159495 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Adult Acute Myeloid Leukemia in Remission, Acute Biphenotypic Leukemia.
What interventions are being tested in trial NCT02159495?
The interventions under investigation include: laboratory biomarker analysis (OTHER), Fludarabine Phosphate (DRUG), cyclophosphamide (DRUG), Autologous CD123CAR-CD28-CD3zeta-EGFRt-expressing T Lymphocytes (BIOLOGICAL), Allogeneic CD123CAR-CD28-CD3zeta-EGFRt-expressing T-lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT02159495?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02159495 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02159495's enrollment target sits among peer trials
31 203rd of 306 higher than 104 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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